The present invention relates generally to application of nickel-titanium alloys to medical devices. More precisely, the present invention is directed to cold worked nickel-titanium alloys that have pseudoelastic behavior without a phase transformation or onset of stress-induced martensite as applied to a medical device deployed from a sheath.
Near equi-atomic binary nickel-titanium alloys (nitinol) are known to exhibit “pseudoelastic” behavior when given certain cold working processes or cold working and heat treatment processes following hot working. Generally speaking, “pseudoelasticity” is the capacity of the nickel-titanium alloy to undergo large elastic strains on the order of 8 percent or more when stressed and to substantially fully recover all strain upon removal of the stress. Substantially full recovery is typically understood to be less than 0.5 percent unrecovered strain, also known as permanent set or amnesia.
Pseudoelasticity can be further divided into two subcategories: “linear” pseudoelasticity and “non-linear” pseudoelasticity. “Non-linear” pseudoelasticity is sometimes used by those in the industry synonymously with “superelasticity.”
Linear pseudoelasticity results from cold working only. Non-linear pseudoelasticity results from cold working and subsequent heat treatment. Non-linear pseudoelasticity, in its idealized state, exhibits a relatively flat loading plateau in which a large amount of recoverable strain is possible with very little increase in stress. This flat plateau can be seen in the stress-strain hysteresis curve of the alloy. Linear pseudoelasticity exhibits no such flat plateau. Non-linear pseudoelasticity is known to occur due to a reversible phase transformation from austenite to martensite, the latter more precisely called “stress-induced martensite” (SIM). Linear pseudoelasticity has no such phase transformation associated with it. Further discussions of linear pseudoelasticity can be found in, for example, T. W. Duerig, et al., “Linear Superelasticity in Cold-Worked Ni—Ti,” Engineering Aspects of Shape Memory Alloys, pp. 414-19 (1990).
Because of the useful nature of the nickel-titanium alloy, some have attempted to change its properties to solve different design needs. For example, U.S. Pat. No. 6,106,642 to DiCarlo et al. discloses annealing nitinol to achieve improved ductility and other mechanical properties. U.S. Pat. No. 5,876,434 to Flomenblit et al. teaches annealing and deforming nitinol alloy to obtain different stress-strain relationships.
Binary nickel-titanium alloys have been used in the medical field. Many medical device related applications exploit the non-linear pseudoelastic capabilities of nitinol. Examples include: U.S. Pat. Nos. 4,665,906; 5,067,957; 5,190,546; and 5,597,378 to Jervis; and U.S. Pat. Nos. 5,509,923; 5,486,183; 5,632,746; 5,720,754; and 6,004,629 to Middleman, et al.
Yet another application of nickel-titanium alloys is in an embolic protection or filtering device. Such embolic filtering devices and systems are particularly useful when performing balloon angioplasty, stenting procedures, laser angioplasty, or atherectomy in critical vessels, particularly in vessels such as the carotid arteries, where the release of embolic debris into the bloodstream can occlude the flow of oxygenated blood to the brain or other vital organs. Such an occlusion can cause devastating consequences to the patient. While the embolic protection devices and systems are particularly useful in carotid procedures, they are equally usefull in conjunction with any vascular interventional procedure in which there is an embolic risk. An embolic protection device that uses superelastic nitinol recently released to the market by the Cordis Corporation is known as the ANGIOGUARD.
What has been needed and heretofore unavailable in the prior art is a medical device that exploits the benefits of linear pseudoelastic nitinol. With the use of linear pseudoelastic nitinol, the mechanical strength of the device is substantially greater per unit strain than a comparable device made of superelastic nitinol. Furthermore, smaller component parts such as struts can be used because of the greater storage of energy available in a linear pseudoelastic nitinol device.